AccessGUDID - DEVICE: T.E.D. (10884521024151)

GUDID

Device Identifier (DI) Information

Brand Name: T.E.D.
Version or Model: 3221
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3221
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521024151
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Anti-Embolism Stockings,Thigh Length with Belt,Large,Regular,Size E+

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
30878	Compression/pressure sock/stocking, single-use	A garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWL	Stocking, medical support (to prevent pooling of blood in legs)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: ;

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 182aaad4-cfc4-4dd5-85ab-973ff92aa4ba
Public Version Date: July 03, 2023
Public Version Number: 9
DI Record Publish Date: May 24, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20884521024158	6	10884521024151	2023-07-01	Not in Commercial Distribution	PACK_OR_INNER_PACK
30884521024155	36	10884521024151	2023-07-01	Not in Commercial Distribution	CASE

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(508)261-8000
Email: covidien.udi@covidien.com

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